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Stacy Lewis

has been a Law Clerk at Finnegan for over 20 years and has co-authored dozens of articles about U.S. patent law. She is also the coordinating editor of the treatises Chemical Patent Practice and Global Patent Litigation: How and Where to Win.

Recent Articles by Stacy Lewis

What are the Priority Date, Patent Term, and Effective Filing Date of a Patent: The Roles of Specific Reference, Incorporation by Reference, and Claim Support

A recent Federal Circuit decision demonstrates that for priority claims and patent term, the phrase “specific reference” is key. For example, amongst three related applications, to get the benefit of priority of an earlier U.S. patent application 1, application 3 in a priority claim has to have a “specific reference” to earlier application 1. A mere priority claim in application 3 to application 2, even though application 2 specifically “incorporates by reference” application 1, is not sufficient to allow application 3 to rely on the filing date of application 1. Rather, the priority chain is broken between applications 2 and 1, leaving application 3, at best, with a priority date of application 2 for purposes of patentability… From the Federal Circuit in Droplets, practitioners are reminded that both priority claims and incorporation by reference are very specific tools that should not be relied on during prosecution without careful consideration and deliberate use. Certainly, incorporation by reference does not trump “specific reference” and may lead to a break in the priority chain for purposes of patentability.

Patenting Antibodies: Written Description Considerations in Antibody Patents

The Amgen v. Sanofi decision put most functional antibody claims into question, including epitope and competitive binding claims, as well as antibody claims based on a newly characterized antigen. After Amgen v. Sanofi, non-sequence based antibody claims may become more difficult to obtain before the USPTO from a written description standpoint.  Yet, to fully protect the essence of the invention and avoid design-arounds, such claims are extremely valuable to patent owners. To obtain antibody genus claims beyond those defined by sequences, the patent applicant will need to make and test a sufficient number of representative antibodies across the claimed genus, or establish a clear structure/function relationship among the members of the genus.  Patent applicants should carefully assess the amount of data they have acquired, in comparison to the scope of claims that they wish to obtain, before rushing to the Patent Office.

Patenting Antibodies: Obviousness Considerations

This article analyzes obviousness issues related to antibody patents at the Patent Trials and Appeal Board (PTAB) and in federal courts. We review several cases categorized by type of claims in search of trends on what types of antibody-related claims are more likely to survive an obviousness challenge… These cases are highly fact-specific, but a few broad observations may be made. To our knowledge, no claims directed to an antibody claimed purely by structure have been challenged, except for those of an ADC (KADCYLA®), where both the antibody part and the drug part of the conjugate were previously known. An antibody broadly claimed by function may be considered obvious “[i]f any one method of achieving any single embodiment [of such claim] would have caused a person of ordinary skill in the art to anticipate success.” Abbott GMBH, 971 F. Supp.2d at 186. Objective indicia of nonobviousness have been helpful, but only where there was a clear nexus between the objective evidence and the claims.